Order Code RL31015 CRS Report for Congress Received through the CRS Web Stem Cell Research Updated July 18, 2005 Judith A. Johnson Specialist in Life Sciences Domestic Social Policy Division Erin D. Williams Specialist in Bioethical Policy Domestic Social Policy Division Congressional Research Service ˜ The Library of Congress Stem Cell Research Summary Embryonic stem cells have the ability to develop into virtually any cell in the body, and they may have the potential to treat medical conditions such as diabetes and Parkinson’s disease. In August 2001, President Bush announced that for the first time federal funds would be used to support research on human embryonic stem cells, but funding would be limited to “existing stem cell lines.” The National Institutes of Health (NIH) has established the Human Embryonic Stem Cell Registry, which lists 78 stem cell lines that are eligible for use in federally funded research. However, only 22 embryonic stem cell lines are currently available. Scientists are concerned about the quality, and longevity of these stem cell lines. For a variety of reasons, many believe research advancement requires new embryonic stem cell lines, and for certain applications, stem cells derived from cloned embryos may offer the best hope for progress in understanding and treating disease. A significant cohort of pro-life advocates support stem cell research; those opposed are concerned that the isolation of stem cells requires the destruction of embryos. Some have argued that stem cell research be limited to adult stem cells obtained from tissues such as bone marrow. They argue that adult stem cells should be pursued instead of embryonic stem cells because they believe the derivation of stem cells from either embryos or aborted fetuses is ethically unacceptable. Other scientists believe adult stem cells should not be the sole target of research because of important scientific and technical limitations. Some scientists are exploring the possibility of obtaining human embryonic stem cells that bypass the destruction of living human embryos. The President’s Council on Bioethics identified four potential alternative sources of human embryonic stem cells in a paper released in May 2005. On May 24, 2005, the House passed H.R. 810 (Castle) which would allow federal support of research that utilizes human embryonic stem cells regardless of the date on which the stem cells were derived from a human embryo, thus negating the Bush stem cell policy limitation on “existing stem cell lines.” On the same day, the House also passed H.R. 2520 (Christopher Smith) which would provide for the collection and maintenance of human cord blood stem cells for the treatment of patients and for research. During consideration of Labor-HHS appropriations, Members may renew efforts to alter or abolish the Dickey Amendment in order to permit embryo research and the development of stem cell lines with federal support. Action on the Weldon bill (which passed the House in the 107th and 108th and stalled in the Senate) is also likely; it has been reintroduced in the 109th Congress as H.R. 1357 and S. 658 (Brownback). The bill bans the process of cloning as well as the importation of any product derived from an embryo created via cloning. It bans not only reproductive applications, but also research on therapeutic uses, which has implications for stem cell research. Advocates of the legislative ban say that allowing any form of human cloning research to proceed raises serious ethical issues and will inevitably lead to the birth of a baby that is a human clone. Critics argue that the measure would curtail medical research and prevent Americans from receiving life-saving treatments created overseas. This report will be updated as needed. Contents Overview of Basic Research and Potential Applications................1 Embryonic Stem Cells from IVF Embryos or Fetal Tissue..........1 Embryonic Stem Cells Obtained via SCNT (Cloning) .............1 Alternative Sources of Human Embryonic Stem Cells.............2 Stem Cells from Adult Tissue or Umbilical Cord Blood............4 Potential Applications of Stem Cell Research....................4 Current Federal Regulatory Landscape .............................5 The Dickey Amendment and Clinton Administration Stem Cell Policy ......................................5 Bush Administration Stem Cell Policy .........................8 Agency Regulation: FDA and NIH............................9 Concerns Over Access to Stem Cell Lines .........................12 Reproductive Genetics Institute ..............................12 Harvard Stem Cell Institute .................................12 Stanford Institute for Cancer/Stem Cell Biology .................13 UCSF Developmental and Stem Cell Biology Program ...........13 Worldwide Survey of Stem Cell Lines ........................13 Congressional Letters on Bush Policy.........................14 National Academies Guidelines..............................15 State Actions on Embryonic Stem Cell Research ....................16 States that Prohibit Research on an Aborted Fetus or Embryo......16 States that Prohibit Research on Tissue Derived from IVF or Cloning ..........................................16 State Initiatives to Encourage Stem Cell Research ...............17 Congressional Actions.........................................20 International Actions on Embryonic Stem Cell Research..............25 Ethical Issues................................................28 Embryo Destruction and Relief of Human Suffering .............31 Viability of Embryos ......................................32 Purpose of Embryo Creation................................32 New and Existing Cell Lines................................33 Consent of Donors ........................................34 Effectiveness of Alternatives................................35 Generating Embryonic Stem Cells Without Destroying Human Embryos .....................................36 Use of Federal Funding ....................................37 List of Tables Table 1. National Institutes of Health Funding ..........................10 Table 2. NIH List of Human Embryonic Stem Cell Lines Eligible for Use in Federal Research........................................11 Stem Cell Research Overview of Basic Research and Potential Applications Most cells within an animal or human being are committed to fulfilling a single function within the body. In contrast, stem cells are a unique and important set of cells that are not specialized. Stem cells retain the ability to become some or all of the more than 200 different cell types in the body and thereby play a critical role in repairing organs and body tissues throughout life. Although the term stem cells is often used in reference to these repair cells within an adult organism, a more fundamental variety of stem cells is found in the early stage embryo. Embryonic stem cells may have a greater ability to become different types of body cells than adult stem cells. Embryonic Stem Cells from IVF Embryos or Fetal Tissue. Embryonic stem cells were first isolated from mouse embryos in 1981 and from primate embryos in 1995. Animal embryos were the only source for research on embryonic stem cells until November 1998, when two groups of U.S. scientists announced the successful isolation of human embryonic stem cells. One group, at the University of Wisconsin, derived stem cells from five-day-old embryos produced via in vitro fertilization (IVF).1 The work is controversial, in the opinion of some, because the stem cells are located within the embryo and the process of removing them destroys the embryo. The second group, at Johns Hopkins University, derived stem cells with very similar properties from five- to nine-week-old embryos or fetuses obtained through elective abortion.2 Both groups reported the human embryos or fetuses were donated for research following a process of informed consent. The cells removed from embryos or fetuses were manipulated in the laboratory to create embryonic stem cell lines that may continue to divide for many months to years. Embryonic Stem Cells Obtained via SCNT (Cloning). Another potential source of embryonic stem cells is somatic cell nuclear transfer (SCNT), also 1 The IVF embryos were originally created for the treatment of infertility. Excess embryos are often frozen for future use. A couple may elect to discard their excess embryos, donate the embryos for research, or allow another couple to adopt an embryo. According to a survey of over 430 infertility clinics performed by the Society for Assisted Reproductive Technology and RAND, nearly 400,000 embryos are being stored in the United States; 88% of the embryos are being held to help the couples have children at a later date. 2 Scientists and physicians use the term “embryo” for the first eight weeks after fertilization, and “fetus” for the ninth week through birth. In contrast, the Department of Health and Human Services (HHS) regulations define “fetus” as “the product of conception from the time of implantation” (45 C.F.R. § 46.203). CRS-2 referred to as cloning.3 In SCNT the nucleus of an egg is removed and replaced by the nucleus from a mature body cell, such as a skin cell. The cell created via SCNT is allowed to develop for several days and then the stem cells are removed. In 1996, scientists in Scotland used the SCNT procedure to produce Dolly the sheep, the first mammalian clone.4 In May 2005 scientists at the Seoul National University in South Korea announced they had achieved major